Senior Purification Manufacturing Associate

KBI Biopharma; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

KBI Biopharma in Durham, NC seeks a Sr. Manufacturing Associate to perform upstream or downstream bioprocessing and support operations. This role follows GMP/GLP with strict documentation and RFT, authoring SOPs/MBRs, CAPAs, and qualifying equipment.

Responsibilities include upstream/downstream operations, equipment knowledge, and cross-functional collaboration with QA, MS&T, facilities, and supply chain. 12-hour shifts (6AM-6PM) on a rotating schedule.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline with 4–6 years’ GMP manufacturing operations experience; or high school degree with 7–10 years’ GMP manufacturing operations experience.
• Basic knowledge of upstream (cell culture/fermentation) or downstream (purification/bulk filling) unit operations preferred.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records in compliance with quality standards and regulations.
• Perform operations in a cleanroom with aseptic controls including gowning and cleaning procedures.
• Document each task in manufacturing records and logbooks per GDP at execution time.
• Maintain and operate equipment per applicable SOPs.
• Ensure materials are issued and accounted for during batch execution (SR, EPR, BR).
• Demonstrate and apply CGMP understanding to tasks and responsibilities.
• Participate in 5S workplace organization and continuous improvement.
• Provide direction to Manufacturing Associates and assist supervisor with workload distribution.

Skills

GMP knowledge

GLP knowledge

SOP writing

CAPA writing

Documentation

Team collaboration

Communication skills

Education

Bachelor’s degree in science/engineering

High school with GMP experience

Tools

MS Office

ERP

EDMS

Job description

KBI Biopharma in Durham, NC seeks a Sr. Manufacturing Associate to perform upstream or downstream bioprocessing and support operations. This role follows GMP/GLP with strict documentation and RFT, authoring SOPs/MBRs, CAPAs, and qualifying equipment.

Responsibilities include upstream/downstream operations, equipment knowledge, and cross-functional collaboration with QA, MS&T, facilities, and supply chain. 12-hour shifts (6AM-6PM) on a rotating schedule.